PMDA drug package insert
アクチバシン注600万
PMDA Prescription drug · 協和キリン株式会社 · package insert May 7, 2024
Key facts
| Brand names | アクチバシン注600万, アクチバシン注1200万, アクチバシン注2400万 |
|---|---|
| Nonproprietary names | アルテプラーゼ（遺伝子組換え） |
| Companies | 製造販売元／協和キリン株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 血栓溶解剤（rt-PA製剤） |
| Therapeutic category codes | 873959 |
| YJ codes | 3959402D1027, 3959402D2023, 3959402D3020 |
| Approval numbers | 20300AMZ00230, 20300AMZ00231, 20300AMZ00232 |
| Package insert edition | 第2版 |
| Package insert date | May 7, 2024 |
| PMDA document key | 230124_3959402D1027_1 |
| PMDA company code | 230124 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- Yes PMDA review report published
- No Risk management plan (RMP)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMDA approved drugs and package inserts (Japan)
Japan's PMDA publishes the package insert (添付文書) of every prescription drug, OTC drug and regenerative medical product, with brand and nonproprietary names, YJ codes and approval numbers. Names appear in Japanese as published.
Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan, package insert database · Source date: